U.S. patent number 8,287,469 [Application Number 11/971,410] was granted by the patent office on 2012-10-16 for articulating surgical device and method of use.
This patent grant is currently assigned to Ethicon Endo-Surgery, Inc.. Invention is credited to Ragae M. Ghabrial, James T. Spivey, David Stefanchik.
United States Patent |
8,287,469 |
Stefanchik , et al. |
October 16, 2012 |
Articulating surgical device and method of use
Abstract
Various embodiments of an elongate surgical device configured to
travel along a tortuous body lumen to a surgical site are provided
herein. In one embodiment, the device can include a tensioning
element extending through a channel formed along a length of the
device and the tensioning element can translate an articulation
force to the working end of the device. During such articulation of
the device, a portion of the channel can be configured to allow the
tensioning element to exit the channel and move away from a
longitudinal axis of the device thereby optimizing a mechanical
advantage relative to the distal end of the device and thus
maximizing the force capable of being delivered thereto.
Additionally, various embodiments of a method for articulating a
working end of an elongate surgical device are provided herein.
Inventors: |
Stefanchik; David (Morrow,
OH), Ghabrial; Ragae M. (Cincinnati, OH), Spivey; James
T. (Cincinnati, OH) |
Assignee: |
Ethicon Endo-Surgery, Inc.
(Cincinnati, OH)
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Family
ID: |
40445858 |
Appl.
No.: |
11/971,410 |
Filed: |
January 9, 2008 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20090177041 A1 |
Jul 9, 2009 |
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Current U.S.
Class: |
600/585;
600/146 |
Current CPC
Class: |
A61B
17/3421 (20130101); A61B 17/29 (20130101); A61B
1/00073 (20130101); A61B 1/0014 (20130101); A61B
2017/003 (20130101); A61B 17/2909 (20130101); A61B
2017/00477 (20130101); A61B 2017/3447 (20130101) |
Current International
Class: |
A61B
5/00 (20060101) |
Field of
Search: |
;600/146,585
;606/130 |
References Cited
[Referenced By]
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Other References
International Search Report, from PCT/US08/087340, mailed Apr. 6,
2009. cited by other .
International Preliminary Report on Patentability Jul. 13, 2010 for
Application No. PCT/US08/087340 (7 Pages). cited by other.
|
Primary Examiner: Towa; Rene
Assistant Examiner: Danega; Renee
Claims
What is claimed is:
1. A surgical device, comprising: a flexible elongate shaft having
proximal and distal ends; a tensioning element extending through a
channel formed along a length of the elongate shaft, the channel
having at least one opening configured to allow a portion of the
tensioning element to exit the channel in response to a tension
applied to the tensioning element and bend at least a portion of
the elongate shaft, the tensioning element exiting the channel
adjacent to the at least a portion of the elongate shaft that
bends; and a retaining element extending around the at least a
portion of the elongate shaft that bends such that, when the
retaining element is disposed around a bent portion of the elongate
shaft, the retaining element allows the tensioning element at the
bent portion of the elongate shaft to exit through the at least one
opening, and limits displacement of the tensioning element at the
bent portion of the elongate shaft.
2. The device of claim 1, wherein the shaft comprises a sleeve
having an inner lumen extending between proximal and distal ends
for providing access to a surgical site.
3. The device of claim 1, wherein the tensioning element is a
cable.
4. The device of claim 1, further comprising an actuator coupled at
the proximal end of the at least a portion of the elongate shaft,
the actuator configured to apply tension to the tensioning element
thereby bending the portion of the elongate shaft.
5. The device of claim 1, wherein the retaining element comprises a
spiral wire.
6. The device of claim 5, wherein a diameter of the spiral wire is
selected to limit a distance that the tensioning element can move
out of the channel.
7. The device of claim 1, wherein the channel comprises a lumen
extending through a sidewall of the elongate shaft.
8. The device of claim 7, wherein the opening is located adjacent
to the distal end of the elongate shaft.
9. The device of claim 1, wherein the tensioning element includes a
first cable extending through a first channel in the elongate shaft
and a second cable extending through a second channel in the
elongate shaft.
10. The device of claim 9, wherein the first channel comprises a
first lumen extending through a sidewall of the elongate shaft
having a first opening formed therein, the first opening being
configured to allow a portion of the first tensioning element to
exit the first channel therethrough, and the second channel
comprises a second lumen extending through the sidewall of the
elongate shaft having a second opening formed therein, the second
opening being configured to allow a portion of the second
tensioning element to exit the second channel therethrough.
11. The device of claim 10, wherein the first opening and the
second opening are located adjacent to the distal end of the
elongate shaft.
12. A surgical device, comprising: a flexible elongate sleeve
having proximal and distal ends with an inner lumen having a
longitudinal axis extending therethrough, the inner lumen
configured for delivery of surgical instruments to a surgical site;
a tensioning element extending between proximal and distal ends of
the elongate sleeve and coupled to the elongate sleeve such that at
least one portion of the tensioning element is configured to
deflect away from the longitudinal axis of the inner lumen and
extend through at least one opening on the elongate sleeve in
response to a tension applied to the tensioning element; and a
retaining element spiraling around a portion of the elongate sleeve
having the at least one opening, wherein a distance between each
spiral is selected to limit a distance that the tensioning element
extends beyond the at least one opening on the elongate sleeve.
13. The device of claim 12, further comprising a mating element
extending along a length of the flexible elongate sleeve, and
configured to detachably engage a mating element formed on a second
flexible elongate sleeve.
14. The device of claim 12, wherein the tensioning element includes
a first cable and a second cable, the first and second cables
extending between the proximal and distal ends of the elongate
sleeve and coupled to the elongate sleeve.
15. The device of claim 14, wherein a distal end of the first cable
is mated to the elongate sleeve at a first distance proximal to the
distal end of the sleeve, and a distal end of the second cable is
mated to the elongate sleeve at a second distance proximal to the
distal end of the sleeve and greater than the first distance.
16. A method for processing the device of claim 12 for surgery,
comprising: a) obtaining the device of claim 12; b) sterilizing the
device; and c) storing the device in a sterile container.
17. A method for articulating a flexible elongate sleeve,
comprising: delivering a flexible elongate device having at least
one opening along a tortuous body to a surgical site; applying
tension to a tensioning element extending through the elongate
device, causing a portion of the tensioning element to pass through
the at least one opening and thereby bending a portion of the
elongate device; and delivering a surgical instrument to the
surgical site through the flexible elongate device; wherein a
retaining element extends along a length of the bent portion of the
elongate device and engages the tensioning element as the
tensioning element moves through the at least one opening and
prevents movement of the tensioning element beyond the retaining
element.
18. The method of claim 17, wherein the tensioning element includes
a first cable and a second cable, and the method further comprises
applying tension to the first cable extending through the elongate
device, causing a portion of the first cable to pass through an
opening and thereby bending a first portion of the elongate sleeve
in a first orientation; and applying tension to the second cable
extending through the elongate device, causing a portion of the
second cable to pass through an opening and thereby bending a
second portion of the elongate sleeve in a second orientation.
19. The method of claim 17, further comprising delivering a
surgical instrument through an inner lumen of the elongate device
to a surgical site to perform a surgical procedure.
20. The method of claim 17, further comprising sterilizing the
device after at least one use.
Description
FIELD OF USE
The present disclosure relates to articulation of surgical devices,
in particular to articulation of a working end of a flexible,
elongate surgical device.
BACKGROUND
Endoscopic surgical instruments are often preferred over
traditional open surgical devices since the use of a natural
orifice tends to reduce the post-operative recovery time and
complications. Consequently, significant development has gone into
a range of endoscopic surgical instruments that are suitable for
precise placement of a working end of a tool at a desired surgical
site through a natural orifice. These tools can be used to engage
and/or treat tissue in a number of ways to achieve a diagnostic or
therapeutic effect.
Endoscopic surgery requires that the shaft of the device be
flexible while still allowing the working end to be articulated to
angularly orient the working end relative to the tissue, and in
some cases to be actuated to fire or otherwise effect movement of
the working end. Integration of the controls for articulating
and/or actuating a working end of an endoscopic device tend to be
complicated by the use of a flexible shaft and by the size
constraints of an endoscopic instrument. Generally, the control
motions are all transferred through the shaft as longitudinal
translations, which can interfere with the flexibility of the
shaft. There is also a desire to lower the force necessary to
articulate and/or actuate the working end of the device to a level
that all or a great majority of surgeons can handle. One known
solution to lower the "force-to-fire" is to use electrical motors.
However, surgeons typically prefer to experience feedback from the
working end to assure proper operation of the end effector. The
user-feedback effects are not suitably realizable in present
motor-driven devices.
Thus, there remains a need for an easy to use and reliable device
and method capable of articulating a working end of an elongate,
flexible surgical instrument.
SUMMARY
Devices and methods for articulating a working end of an elongate
surgical device are provided. In general, the presently disclosed
embodiments utilize a tensioning element (e.g., one or a plurality
of cables) extending along a length of the surgical device and
having a distal end engaged to a working end of the sleeve. In use,
the tensioning element can be slidably disposed within the device
in such a manner capable of enhancing a user's mechanical advantage
over the working end of the device thereby enabling a greater
amount of force to be transferred to the working end of the device
during articulation. As described in detail below, in one
embodiment the tensioning element can be slidably disposed within a
channel formed in a wall of the device which defines an inner lumen
extending along the length of the device. The channel can further
include any number, configuration, and/or dimension of opening(s)
in communication with the channel-defined inner lumen. In use, the
opening(s) can be positioned and configured to allow the tensioning
element disposed within the channel to exit the channel through the
opening(s) during articulation of the device. In other words,
during articulation, the tensioning element can move out of the
opening and away from a longitudinal axis of the surgical device
thereby creating a leverage and/or an enhanced mechanical advantage
over a working end of the surgical device. Thus, the presently
disclosed embodiments provide an easy to use device and method
capable of enhancing the ability to articulate an elongate surgical
device while also increasing the functionality and performance of
the device by enhancing the user's mechanical advantage over the
working end.
Various aspects of such a surgical device are provided herein. In
one such aspect, the surgical device includes a flexible elongate
shaft having proximal and distal ends. For example, the elongate
shaft can be a sleeve having an inner lumen extending between
proximal and distal end for providing access to a surgical site.
The device also includes a tensioning element (e.g., one or a
plurality of cables, wires, etc.) extending through a channel
formed along a length of the elongate sleeve between the proximal
and distal ends wherein at least a portion of the channel can be
configured to allow the tensioning element to exit the channel in
response to a tension applied to the tensioning element. The
tensioning element can be any element capable of providing tension
to the elongate shaft. For example, the tensioning element can be
one or any number of cables, cords, fibers, wires, etc. As
indicated above, the tensioning element can be slidably disposed
within a channel extending along a length of the shaft. In an
exemplary embodiment, the channel can include one or more openings
formed along the channel and the opening(s) can be configured to
allow a portion of the tensioning element to exit the channel
through the opening during articulation of the sleeve. As will be
described below, various numbers, configurations, and/or dimensions
of openings can be located at virtually any position along the
length of the elongate shaft and/or along the length of the
channel. For example, an opening can be positioned adjacent to the
distal end of the elongate shaft, the opening can be positioned
along a proximal portion of the shaft, the opening can be
positioned at a location proximal of the distal end of the shaft,
etc. Additionally, an opening can extend along any length of the
channel as desired to provide the desired mechanical advantage.
In one embodiment, the device can be configured to limit the
distance the tensioning element can exit the channel thereby
providing some desired degree of rigidity and/or stability to the
shaft. For example, the device can include a retaining element
(e.g., a cable, a wire, a suture, a sleeve, etc.) positioned (e.g.,
spiraled or wrapped) around the elongate shaft. More specifically,
the retaining element can be positioned adjacent an opening so as
to limit movement of the tensioning element away from the channel.
In one embodiment, a distance between each subsequent spiral as
well as the diameter of each spiral can be selected to provide a
desired degree of rigidity and/or stability to the elongate
shaft.
The presently disclosed device can also include an actuator coupled
to the proximal end of the elongate shaft. The actuator can be
configured to apply tension to the tensioning element thereby
bending (or articulating) the elongate shaft in a desired
configuration. Virtually any type of actuator capable of delivering
tension to the tensioning element is within the spirit and scope of
the present disclosure. For example, the actuator can be a movable
(e.g., pivotable) handle element configured to apply an axial force
to the distal end of the tensioning element. In other embodiments,
the actuator can include various spool elements in communication
with the tensioning element such that, for example, a first spool
element can control manipulation of a first cable, and a second
spool element can control manipulation of a second cable. In short,
the actuator can include any type of mechanism capable of providing
a force to the distal end of the tensioning element which is then
capable of translating the force to the working end of the device
to enable to the desired articulation.
In another aspect, a surgical device is provided which includes a
flexible elongate sleeve having proximal and distal ends with an
inner lumen having a longitudinal axis extending therethrough. In
use, the inner lumen is configured to provide access to a surgical
site for various tools or instruments. The device can also include
a tensioning element (e.g., at least one cable, wire, cord, etc.)
extending between the proximal and distal ends of the elongate
sleeve. The tensioning element can be slidably coupled to the
elongate sleeve such that a distance between the longitudinal axis
of the inner lumen of the sleeve and a portion of the tensioning
element can increase in response to a tension being applied to the
tensioning element. As described below, such an increase in
distance can provide an enhanced mechanical advantage over the
working end of the device which thereby enables a greater amount of
force to be transferred to the desired area of the device (e.g.,
the working end).
As indicated, the tensioning element can include any number of
cables (e.g., 1, 2, 3, 4, etc.) extending along a length of the
sleeve. For example, the tensioning element can include a first
cable extending through a first channel in the elongate sleeve, and
a second cable extending through a second channel in the elongate
sleeve. As indicated above, each channel can be configured so as to
allow the cable disposed therein to exit the channel during
articulation of the sleeve. Similar to above, each channel can be
formed within the elongate sleeve. Additionally, each channel can
further be in communication with any number of openings (e.g., a
first opening in communication with the first channel and a second
opening in communication with the second channel) formed within the
elongate sleeve. For example, a first opening can be configured to
allow a portion of the first cable to exit the first channel
therethrough, and the second opening can be configured to allow a
portion of the second cable to exit the second channel
therethrough. The first and second openings can have any length and
can be formed at virtually any location along the length of the
elongate sleeve (e.g., adjacent to the distal end of the sleeve,
positioned along a proximal end, etc.). The device can also
include, similar to above, a retaining element (e.g., a spiral
wire) extending along a length of the device and configured to
retain or limit the distance the first and the cables move away
from their respective channels through their respective
openings.
In yet another embodiment, the elongate surgical sleeve can be
configured as an accessory channel capable of being coupled to a
second elongate surgical sleeve (e.g., an endoscopic device). In
such an embodiment, the elongate sleeve can include a mating
element (e.g., a rail) extending along a length thereof and
configured to detachably engage a corresponding mating element
formed on the second flexible elongate sleeve.
Additionally, various aspects of a method of articulating a
flexible elongate device are provided herein. In one such
embodiment, the method includes delivering a flexible elongate
device along a tortuous body lumen to a surgical site wherein the
elongate device can include an inner lumen defining a longitudinal
axis. The method can also include applying tension to a tensioning
element (e.g., at least one cable, wire, cord, etc.) extending
through the elongate device so as to increase a distance between
the longitudinal axis of the device and a portion of tensioning
element and thereby cause a portion of the elongate device to bend
(or articulate). In one embodiment, the tensioning element can
include a first cable and a second cable, and the method can
further include applying tension to the first cable extending
through the elongate device to increase a distance between the
longitudinal axis of the device and a portion of the first cable.
In use, application of such a force can cause a first portion of
the elongate device to bend in a first desired orientation.
Further, the method can also include applying a tension to the
second cable extending through the elongate device to increase a
distance between the longitudinal axis of the device and a portion
of the second cable. Like above, this force can cause a second
portion of the elongate device to bend in a second orientation. In
another embodiment, the method can further include controlling the
distance between the longitudinal axis of the device and the
tensioning element by spiraling, looping, or otherwise positioning
a retaining element (e.g., a cable, wire, etc.) around a portion of
the elongate device. Similar to above, the retaining element can be
configured to engage the tensioning element as the element moves
out of an opening formed in the channel and away from the
longitudinal axis of the elongate device.
The methods can also include delivering a surgical instrument to a
treatment site via an inner lumen of the elongate device so as to
perform some desired surgical procedure. In other embodiments, the
method can include various sterilization and/or processing
procedures or steps. For example, the method can include
sterilizing the device (or any component thereof) after at least
one use. In another example, the method can include obtaining any
embodiment of the surgical device, sterilizing the device, and
storing the surgical device in a sterile container.
BRIEF DESCRIPTION OF THE DRAWINGS
Exemplary embodiments of the present disclosure will be more fully
understood from the following detailed description taken in
conjunction with the accompanying drawings, in which:
FIG. 1 is a perspective view of one exemplary embodiment of an
elongate surgical device;
FIG. 2A is a perspective view of a distal end of the elongate
surgical device of FIG. 1;
FIG. 2B is a representation of a tensioning element having a
plurality of cables;
FIG. 2C is a cross-sectional view taken along line 2C-2C of the
device of FIG. 1;
FIG. 3A is a perspective view of a distal portion of the elongate
surgical device of FIG. 1 in an articulated configuration;
FIG. 3B is a top view of the distal portion of the device of FIG.
3A;
FIG. 4 is a side view of the surgical device of FIG. 1 having a
retaining element spiraled around a portion of the device;
FIG. 5 is a side view of another embodiment of a surgical device
having a steering assembly slidably coupled thereto;
FIG. 6A is a perspective view of another embodiment of a surgical
device having an end effector coupled to a distal end of an
elongate shaft;
FIG. 6B is a side view of the surgical device of FIG. 6A showing
the device is in an articulated configuration; and
FIG. 7 is a cross-sectional view of an embodiment of a surgical
device having a handle with a pulley system for articulating the
device.
DETAILED DESCRIPTION
Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein.
One or more examples of these embodiments are illustrated in the
accompanying drawings. Those skilled in the art will understand
that the devices and methods specifically described herein and
illustrated in the accompanying drawings are non-limiting exemplary
embodiments and that the scope of the present disclosure is defined
solely by the claims. The features illustrated or described in
connection with one embodiment may be combined with the features of
other embodiments. Such modifications and variations are intended
to be included within the scope of the present disclosure.
Various embodiments of a device and method for controlling,
manipulating, and/or articulating a working end of an elongate
surgical device are provided herein. The present disclosure
includes virtually any type of surgical instrument configured to
travel along a tortuous body lumen to a surgical site. As described
below, the device includes a tensioning element (e.g., one or any
number of cables, wires, cords, etc.) extending from a proximal
handle portion to a working end of the device. More specifically,
the tensioning element includes a distal end engaged to a working
end of the device and a proximal portion in communication with an
actuator. In use, as an actuation force is supplied to the
actuator, the tensioning element can move from a slackened state to
a tensioned state thereby exerting a pulling force on the distal
end of the device, thus causing the distal end to articulate, i.e.,
move in a direction away from a central axis of the device. In an
exemplary embodiment, the device includes at least one channel
formed in a wall thereof and extending from the proximal to distal
end of the sleeve. The channel(s) can define an inner lumen which
is configured to slidably receive the tensioning element along the
length of the device. Further, at least a portion of each channel
can be configured (e.g., by including at least one opening in
communication with the inner lumen) such that the tensioning
element can exit the channel at one or more regions thereof during
articulation of the device. As described below, allowing the
tensioning element to exit the channel and therefore move away from
a longitudinal axis of the device during articulation can provide
leverage and an enhanced mechanical advantage over a distal end of
the device. Thus, the presently disclosed embodiments maximize an
amount of force being supplied to the working end of the device
thereby increasing the effectiveness and functionality of the
surgical device.
FIG. 1 provides one exemplary embodiment of an articulating device.
As shown, the device 10 includes an elongate sleeve 12 having a
proximal end 12a coupled to a handle 14 which is in communication
with an actuator 15. The sleeve 12, as will be apparent to those
skilled in the art, can have virtually any length and/or diameter
as required for a given procedure. Additionally, while the sleeve
12 can have a generally circular cross-sectional shape, those
skilled in the art will appreciate that virtually any
cross-sectional shape is within the spirit and scope of the present
disclosure. Additionally, the sleeve 12 can be formed from
virtually any material(s) capable of providing a flexibility
necessary to navigate a tortuous body lumen. In an exemplary
embodiment, the sleeve 12 can include a flexible portion 16 located
along a length thereof. In such an embodiment, the flexible portion
16 can have a greater flexibility as compared to the remainder of
the sleeve 12 thereby facilitating articulation at the flexible
portion 16. The flexible portion 16 can be formed in a variety of
ways. For example, as shown in detail in FIG. 2A, the flexible
portion 16 can include a number of slits 26 incorporated therein to
provide enhanced flexibility. While the configuration of the slits
26 can vary, in the illustrated embodiment the slits 26 extend
radially around at least a portion of the flexible portion 16, and
the slits 26 are spaced axially apart from one another. Adjacent
slits 26 can also be radially offset from one another. A person
skilled in the art will appreciate that the location, quantity, and
shape of each slit 26 can vary to obtain the desired flexibility.
In other embodiments, the flexible portion 16 can have a smaller
diameter as compared to the remainder of the sleeve 12 or the
flexible portion 16 can be formed of a more flexible material as
compared to the remainder of the sleeve 12. As will be apparent to
those skilled in the art, the flexible portion 16 can be located at
virtually any position along the length of the sleeve and/or the
sleeve can include any number and/or length of such flexible
portions 16.
Looking at FIG. 2A and FIG. 2C, in an exemplary embodiment the
elongate sleeve 12 can include an inner lumen 20 extending through
an outer wall 21 thereby defining a longitudinal axis of the sleeve
12. In use, the inner lumen 20 can be configured to allow for
delivery of various instruments and/or tools to a surgical site.
For example, in one embodiment, the sleeve 12 can be an accessory
sleeve having a rail 24 for mating to a second endoscopic device
(such as an endoscopic sleeve, not shown). In such an embodiment,
various tools can be delivered adjacent to the working end of the
endoscopic device via the inner lumen 20 of the sleeve 12. The
elongate sleeve 12 can also include one or a plurality of bores or
channels 22a-d formed within the outer wall 21 of the sleeve 12,
and each channel 22a-d can define an inner lumen extending from the
distal end 12b to the proximal end 12a of the sleeve 12. As
described below, the inner lumen of each channel 22a-d can be
configured to slidably receive a tensioning element, such as a
cable 18a-d, thereby allowing each tensioning element to extend
along the entire length of the sleeve 12. Thus, as an actuation
force is supplied to each cable 18a-d, the cables 18a-d can slide
proximally within the corresponding channels 22a-d while
translating the force to the distal end 12b of the sleeve 12. As
will also be described below, the channels 22a-d can be configured
such that during articulation, a maximum amount of force can be to
transferred to the distal end of the sleeve 12 thereby enhancing
the functionality of the device.
Referring to FIG. 1, the tensioning element 18 (shown as a dashed
line) can extend between a proximal portion (e.g., a handle 14) of
the device and a distal portion 12b of the sleeve 12. More
specifically, the distal end of the tension element 18 can be
engaged to a working end of the sleeve 12, and a proximal end or
portion of the tensioning element 18 can be in communication with
an actuator 15 capable of translating an actuation force to the
tensioning element 18. In use, as the actuation force is supplied
to the actuator 15 (discussed below), the tensioning element 18 can
move from a slackened state to a tensioned state thereby exerting a
pulling force on the distal end 12b of the sleeve 12 which results
in some degree of articulation (see FIG. 3A) of the shaft 12. The
tensioning element 18 can include virtually any type of element or
mechanism capable of exerting the desired force on the distal end
12b of the sleeve 12. For example, the tensioning element 18 can
include one (see FIG. 1) or a plurality (see FIG. 2A) of cables,
wires, cords, etc. extending along the length of the sleeve 12. In
an exemplary embodiment shown in FIG. 2A, the tensioning element
includes four cables 18a-d extending along the sleeve 12 generally
parallel to one another and positioned approximately 90 degrees
apart from one another around a circumference of the sleeve 12. In
such a configuration, applying a proximal force to cables 18a, 18c
positioned about 180 degrees from one another can articulate the
sleeve 12 along a first plane of movement (e.g., left and right)
and applying a proximal force to a second set of cables 18b, 18d
positioned about 180 degrees from one another can articulate the
sleeve 12 along a second plane of movement (e.g., up and down). As
will be apparent to those skilled in the art, a tensioning element
having any number and/or relative positioning of cables or other
wires, cords, etc. are within the spirit and scope of the present
disclosure.
The tensioning element 18 can be slidably coupled to the elongate
sleeve 12 in various manners. For example, as mentioned above, in
an exemplary embodiment shown FIGS. 2A-2C, the elongate sleeve 12
can include various channels 22a-d formed therein with each channel
22a-d defining an inner lumen configured to receive a cable 18a-18d
of the tensioning element. In general, the channels 22a-d have a
cross-sectional shape substantially similar to a cross-sectional
shape of a cable 18a-18d disposed therein thereby facilitating
sliding of the cable 18a-18d. FIG. 2B shows a representation of
four cables 18a-d relative to one another when disposed in four
corresponding channels 22a-d of the elongate sleeve 12 (sleeve and
channels being hidden from view). As will be apparent to those
skilled in the art, the distal ends 30a-d of the cables 18a-d of
the tensioning element 18 can be engaged to a desired location
along the length of the corresponding channel 22a-d in virtually
any manner known in the art. For example, referring to FIG. 2B, the
distal end 30a-d of each cable 18a-d can include a ball or
ball-like element having a larger diameter relative to a diameter
of the channel 22a-d. Thus, the cables 18a-d can be sized such that
in an slackened state the ends 30a-d of the cables are positioned
adjacent the distal end of the sleeve 12. Thus, as the cables 18a-d
are moved to a tensioned state (i.e., as an actuation force is
supplied to the actuator), the ends 30a-d of the cables 18a-d can
be pulled into contact with the distal end of the sleeve 12 cause
the sleeve 12 to articulate away from the axis of the sleeve 12. In
other embodiments, the ends 30a-d of the cables 18a-d can be glued,
tied, stapled, or otherwise fixedly attached to the desired
location along the corresponding channel 22a-d. Additionally, in
those embodiments utilizing multiple cables 18a-d, the ends 30a-d
of each cable 18a-d can be engaged at distinct locations along the
length of the sleeve 12 so as to enable various additional modes of
articulation. For example, in one embodiment a distal end 30a of a
first cable 18a can be engaged to a distal-most end of the sleeve
12 and a distal end 30c of a second cable 18c can be engaged to the
sleeve 12 at a location proximal to the distal-most end of the
elongate sleeve 12. In such an embodiment, a first articulation
force can be supplied to the first cable 18a and a second
articulation force can be supplied to the second cable 18c thereby
allowing the sleeve 12 to adopt an "S-shaped" configuration. Thus,
the presently disclosed elongate surgical device can utilize a
tensioning element having any number of cables with distal ends
engaged to virtually any location along the length of the sleeve 12
thereby providing a wide range of possible configurations into
which the sleeve 12 can be articulated or deformed.
In an exemplary embodiment, the various channels 22a-d can be
configured to allow the cables 18a-d disposed therein to achieve an
enhanced mechanical advantage over a working end of the sleeve 12.
For example, referring to FIGS. 3A-3B, the channel 22 can include
one or a plurality of openings 32 in communication with the inner
lumen of the channel 22. During articulation, the opening 32 can be
configured so as to allow the tensioning element 18 to exit the
channel 22 and thereby move away from a longitudinal axis of the
surgical device 10. For example, looking at FIG. 3A, as the sleeve
12 is articulated (e.g., upwards), the tensioning element 18 can
exit the channel 22 through the opening 32 thereby optimizing an
amount of force provided by the tensioning element 18 to the distal
end 12b of the sleeve 12. As will be appreciated by those skilled
in the art, the opening 32 can have any length (l) and/or width (w)
capable of allowing the tensioning element 18 to exit the channel
22 as desired. Further, the channel 22 can include any number of
openings 32 at virtually any location along various lengths
thereof. For example, the opening(s) 32 can be positioned at a
distal end of the channel 22, at a location proximal to the distal
end of the channel 22, at a proximal end of the channel 22, etc.
Also, each channel 22 can include virtually any number of openings
32 as required to provide the desired articulation. For example,
the device 10 can include a channel having a first opening formed
at a location proximal to the distal end of the channel and a
second opening located proximal to the first opening. Also, the
device 10 can include only one channel 22 having at least one
opening 32, the device can include more than one channel 22 having
at least one opening 32, or each channel 22 of the device can
include at least one opening 32. Thus, as will be appreciated by
those skilled in the art, any such embodiment of the device 10
having any number of channels 22 with any number, orientation,
position, and/or dimension of opening(s) 32 in communication with
any number of the channels 22 is within the spirit and scope of the
present disclosure.
The device 10 can also be configured to limit the distance that the
tensioning element 18 can exit an opening 32 of a channel 22
thereby providing a desired degree of rigidity and/or stability to
the device 10. For example, as shown in FIG. 4, the device can
include a retaining element 40 positioned along a length of the
sleeve 12. More specifically, the retaining element 40 can be
positioned adjacent an opening 32 so as to contact and thereby
retain the tensioning element 18 as the tensioning element 18 exits
the opening 32 of the channel 22. As will be appreciated by those
skilled in the art, the retaining element 40 can be any element
configured to retain and/or limit movement of the tensioning
element 18 away from the longitudinal axis of the elongate shaft
12. In an exemplary embodiment, the retaining element 40 is a cable
spiraled around a length of the sleeve 12. In other embodiments,
the retaining element 40 can be a wire, suture, thread, sleeve,
etc. As will be apparent to those skilled in the art, the retaining
element 40 can extend along any desired length of the sleeve 12.
Also, as will be apparent, the retaining element 40 can be a
continuous cable, wire, suture, sleeve, etc., or the retaining
element 40 can be discontinuous. As indicated, in an exemplary
embodiment, the retaining element 40 can be spiraled around the
elongate sleeve 12 of the device 10. In use, a distance between
each spiral and/or a diameter of each spiral can be optimized to
provide a desired degree of stability and/or rigidity. Each spiral
can also be fixedly coupled to a portion of the sleeve 12 to allow
each spiral to maintain a desired diameter, and to allow adjacent
spirals to vary in diameter. In the embodiment shown in FIG. 4, a
rail 24 extends along the shaft 12 of the device 10 and includes a
plurality of openings 25 formed therein which are configured and
positioned to receive each successive spiral of the retaining
element 40. The spirals can be fixed within each opening using
various mating techniques. Alternatively, the spirals can be
slidably disposed through the openings. The spirals can also be
rigid or flexible, and in some embodiments can have a predetermined
shape, e.g., by forming the spirals from a shape memory material or
from another material that retains its shape. In other embodiments,
the retaining element 40 is spiraled around a length of the shaft
12 and not positioned through such openings 25.
Referring to FIG. 5, in another embodiment the device 50 (e.g., an
endoscopic device) can include a steering assembly 54, and the
tensioning element 18 can be engaged to a first distal ring anchor
58 (or similar such anchor) and disposed through a second proximal
ring anchor 56 on the steering assembly 54 thereby allowing for
articulation of the endoscopic device in response to an
articulation force being applied to the tensioning element 18. Like
the embodiments described above, the tensioning element 18 is once
again free to move away from a longitudinal axis of the endoscopic
device during articulation of the device 10 thereby enhancing a
mechanical advantage relative to the distal end of the device 50.
In an exemplary embodiment, the steering assembly 54 can be
slidably coupled (as indicated by arrows), e.g., to a rail 52
formed along a length of the device 50. Thus, the steering assembly
54 can be moved along the length of the rail 52 so as to alter a
point of articulation. As will be appreciated by those skilled in
the art, the steering assembly 54 can include a locking mechanism
for releasably locking the assembly 54 in a desired fixed position
relative to the rail 52, and virtually any mechanism known in the
art can be used.
As indicated above, the surgical device can be virtually any such
device capable of navigating a tortuous body lumen to a surgical
site. As an alternative example, FIGS. 6A-6B provide another
embodiment of a surgical device 100 having an elongate shaft 112
with a proximal end 112a coupled to a handle element 114 and a
distal end 112b coupled to an end effector 116. As will be
appreciated by those skilled in the art, the end effector 116 can
be virtually any such end effector capable of providing a desired
therapeutic function. For example, as shown, the end effector can
be a surgical stapler and cutting device. Assignee's co-pending
U.S. patent application Ser. No. 11/277,323, filed on Mar. 23,
2006, the entirety of which is incorporated herein be reference,
provides a detailed description of such end effectors and their use
with such elongate flexible sleeves.
Referring to FIG. 6B, the device 100 can, similar to the
embodiments described above, include a tensioning element 18
extending from a proximal handle portion 114 (and actuator 115) to
a distal end 112b of the shaft 112. The shaft 112 can also include
a flexible portion 126 formed at a distal end of the device 100
thereby facilitating articulation at the flexible portion 126. The
tensioning element 18 can be disposed within a channel extending
from the proximal to the distal end of the device 100 and the
channel can include an opening configured to allow the element 18
to exit the channel during articulation of the shaft thereby
enhancing a mechanical advantage over a distal end of the device.
Again, the tensioning element 18 can include any number of cables
18a-d extending along a corresponding number of channels extending
along the length of the shaft 112. Additionally, each channel can
include any number of openings formed therein so as to allow the
tensioning element 18 to exit the channel at any desired location
thereof so as to provide the desired articulation.
The various embodiments of the device described herein can include
a handle coupled to a proximal end of the device. In use, the
handle can be in communication with some type of actuator or
actuation mechanism which is in further communication with a
proximal portion of the tensioning element 18. Thus, as a user
supplies an actuation force to the actuator, the tensioning element
18 can move from a slackened state to a tensioned state thereby
translating a force to the distal end of the tensioning element 18
which thereby results in a desired articulation of the sleeve or
shaft. As will be apparent to those skilled in the art, virtually
any type of handle and/or actuator mechanism is within the spirit
and scope of the present disclosure. For example, as show in FIGS.
1 and 7, the actuator 15 can include a first actuation knob 17
configured to apply a force to a first cable by rotating the knob
17 in a first direction (e.g., clockwise), and to apply a force to
a second cable by rotating the knob 17 in an opposite direction
(e.g., counter-clockwise). In an exemplary embodiment, the first
actuation knob 17 can thus control articulation along a first plane
of movement (e.g., left-right) where the first and second cables
extend along opposite sides of the sleeve. Further, the actuator 15
can also include a second articulation knob 19 configured to apply
a force to a third cable by rotating the knob 19 in a first
direction (e.g., clockwise), and to apply a force to a fourth cable
by rotating the knob 19 in an opposite direction (e.g.,
counter-clockwise). Thus, the second articulation knob 19 can
control articulation along a second plane of movement (e.g.,
up-down) where the third and fourth cables extend along opposite
sides of the sleeve and are radially offset about 90 degrees from
the first and second cables. Alternatively, FIGS. 6A-6B provide
another embodiment of a handle 114 and/or actuator 115 which is
movably coupled to a proximal end of the device. In use, as shown
in FIG. 6B, a force can be supplied to the tensioning element 18
(thereby resulting in articulation) by pivoting the actuator 115
relative to the elongate shaft 112 of the device 100, e.g., in a
direction opposite to a desired direction of articulation. A
detailed description of these and other embodiments of a handle
and/or actuator can be found in Assignee's co-pending U.S. patent
application Ser. No. 11/277,323, filed on Mar. 23, 2006, and
Assignee's co-pending U.S. patent application Ser. No. 11/762,855,
filed on Jun. 14, 2007, the entirety of these disclosures being
incorporated herein by reference.
Additionally, various embodiments of a method for articulating a
flexible elongate sleeve are provided herein. Like above, the
method can include articulating virtually any type of flexible
elongate device configured to travel along a tortuous body lumen to
a surgical site. For example, the elongate device can be an
accessory sleeve configured to couple to a second flexible sleeve
(e.g., an endoscopic device). Alternatively, the flexible elongate
device can be a surgical instrument having an end effector (e.g., a
surgical stapler or clip applier, graspers, cutters, coagulators,
etc.) coupled to a distal end thereof. In general, the method can
include delivering the flexible elongate device along a tortuous
body to a surgical site. Similar to those embodiments described
above, the elongate device can include an inner lumen defining a
longitudinal axis. The method can also include applying tension to
a tensioning element extending through the elongate device thereby
articulating the device. In maximizing an amount of force supplied
to the distal end of the device, the device can be configured such
that a distance between the longitudinal axis of the device and a
portion of tensioning element increases during articulation.
Like above, the method can include use of an elongate device having
a tensioning element with any number of cables. For example, the
tensioning element can include a first cable and a second cable. In
such an embodiment, the method can include applying tension to the
first cable which can move away from the longitudinal axis of the
inner lumen of the device in response to such tension. Likewise,
the method can include application of a second force or tension to
the second cable which can also move away from the longitudinal
axis of the device in response to articulation. In short, the
method can utilize a surgical device having any number of cables,
wires, cords, etc., disposed in any number of channels formed
therein. Also, like above, any of the channels can include any
number of openings configured to allow the tensioning element to
move away from the longitudinal axis of the device during
articulation. Also, the method can include controlling the distance
between the longitudinal axis of the inner lumen and the tensioning
element by positioning a retaining element around a portion of the
elongate device such that the retainer element is configured to
engage the tensioning element as the element moves away from the
longitudinal axis.
The method can also include sterilizing any component of any
embodiment of the device after at least one use. More specifically,
the various devices disclosed herein, including portions thereof,
can be designed to be disposed of after a single use, or they can
be designed to be used multiple times. In either case, the device
can be reconditioned for reuse after at least one use.
Reconditioning can include any combination of the steps of
disassembly of the device, followed by cleaning or replacement of
particular pieces, and subsequent reassembly. By way of example,
the elongate surgical sleeve of FIG. 1 and the surgical stapling
and fastening device shown in FIGS. 6A and 6B can be reconditioned
after the device has been used in a medical procedure. The device
can be disassembled, and any number of the particular pieces can be
selectively replaced or removed in any combination. For example,
for the surgical stapling and cutting device, a cartridge disposed
within the end effector and containing a plurality of fasteners can
be replaced by adding a new fastener cartridge to the end effector.
Upon cleaning and/or replacement of particular parts, the device
can be reassembled for subsequent use either at a reconditioning
facility, or by a surgical team immediately prior to a surgical
procedure. Those skilled in the art will appreciate that
reconditioning of a device can utilize a variety of techniques for
disassembly, cleaning/replacement, and reassembly. Use of such
techniques, and the resulting reconditioned device, are all within
the scope of the present application.
Preferably, the various embodiments of the device described herein
will be processed before surgery. First, a new or used instrument
is obtained and if necessary cleaned. The instrument can then be
sterilized. In one sterilization technique, the instrument is
placed in a closed and sealed container, such as a plastic or TYVEK
bag. The container and instrument are then placed in a field of
radiation that can penetrate the container, such as gamma
radiation, x-rays, or high-energy electrons. The radiation kills
bacteria on the instrument and in the container. The sterilized
instrument can then be stored in the sterile container. The sealed
container keeps the instrument sterile until it is opened in the
medical facility.
One skilled in the art will appreciate further features and
advantages of the present disclosure based on the above-described
embodiments. Accordingly, the invention is not to be limited by
what has been particularly shown and described, except as indicated
by the appended claims. All publications and references cited
herein are expressly incorporated herein by reference in their
entirety.
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